3-1

The steps of the evaluation framework are interdependent,

99

3-1

Sources of Variability in Biomarker Measurements,

104

3-2

Information Needed for Package Inserts and Peer-Reviewed Publications Describing Biomarker Assays,

106

3-3

Utilization: Critical and Important Factors for Consideration (Recommendation 1c),

112

4-1

Conditions Associated with High Cardiac Troponins,

157

4-1

Inflammatory risk factors,

144

4-1

Brief Summary of the Results of the Case Studies,

132

4-2

Assays of Inflammatory Markers for Potential Clinical Use,

146

5-1

Expanding FDA Responsibilities,

201

5-2

Core FDA Regulatory Functions,

203

5-3

Dietary Supplements,

212

5-4

Role of NIH in Biomarker Data Collection,

224

5-1

Food and Drug Administration—Regulatory Industry (FY2006): The people, science, and information needed to support innovation, grow industries, and protect the public both in our country and around the world,

202

5-2

Comparison of Food and Drug Administration (FDA) health-related food label statements,

216

5-1

Types of Claims,

210